Cancer ColonNCT05225870
Significance of Cortactin Expression in Colorectal Adenocarcinomas
A study testing immunohistochemical staining in people with Cancer Colon, run by Sohag University at 1 site in Egypt.
Trial summary
Colorectal carcinoma is one of the most aggressive malignant epithelial neoplasms affecting the gastrointestinal tract. The incidence of colorectal carcinoma is obviously increasing in developing countries, where the physical inactivity and the consumption of animal fat-rich food became more evident. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Cancer Colon
- What is being tested?
- immunohistochemical staining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with colorectal carcinomas who underwent colectomy operations.
Who cannot join
- specimens obtained by lower endoscopy only, patients who received pre-operative chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Cortactin Expression is Associated With Increased Tumor Invasiveness and Nodal Metastasis in Egyptian Patients With Colorectal Adenocarcinomas
Colorectal carcinoma is one of the most aggressive malignant epithelial neoplasms affecting the gastrointestinal tract. The incidence of colorectal carcinoma is obviously increasing in developing countries, where the physical inactivity and the consumption of animal fat-rich food became more evident. Colorectal tumorigenesis is a multistep process which is initiated by adenoma and is terminated by carcinoma, the latter shows variable degrees of tumor differentiation and invasiveness. During the adenoma-carcinoma process; a series of genetic mutations occur. Detection of these genetic mutations will help in the development of novel therapeutic agents, which in turn will improve patients' outcomes. Cortactin (CTTN) is a Src kinase substrate, encoded by a gene located on chromosome 11. CTTN binds to and activates Arp 2/3 and stabilizes the dynamic actin assembly after its formation. So, it become clear that CTTN is involved in the formation of the leading-edges cellular protrusions.
Read the detailed description
Colorectal carcinoma is a highly lethal malignant epithelial tumor involving humans. The incidence of colorectal carcinoma is steadily increasing in developing countries, this could be assigned to low physical activity together with high consumption of animal fat-rich food. malignancy of the colon is a multistep process which is initiated by adenoma that proceeds to carcinoma, the latter includes a wide variety of tumor phenotypes. During the adenoma-carcinoma process; a series of genetic and epigenetic alterations occur. Detection of these genetic alterations is of great benefit in the future management of colorectal carcinomas. Cortactin (CTTN) is a Src kinase substrate, encoded by a gene located on chromosome 11. CTTN anchors the dynamic actin assembly . CTTN is implicated in the formation of the leading-edges cellular protrusions.the aim of this study is to evaluate expression of CTTN in 50 cases of colorectal adenocarcinomas and their adjacent normal colonic mucosae.
- Conditions
- Cancer Colon
- Being tested
- immunohistochemical staining
- Keywords
- cancer colon, Cortactin, Immnuohistochemistry
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunohistochemical stainingGenetic
sections from colorectal carcinoma will be immunohistochemically stained by anti-Cortactin antobody.
| Study group | Role | What they receive |
|---|---|---|
| patients with colorectal carcinoma | Other | patients with colorectal carcinoma will undergo colectomy. their colectomy specimens will be sectioned, tissue blocks will be prepared from tumor and adjacent normal mucosa. sections will be stained immunohistochemically by antibody against cortactin. Receives: Genetic: immunohistochemical staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunohistochemical evaluation of Cortactin expression
Fifty patients with colorectal adenocarcinoma will be enrolled in the study. Formalin-fixed and paraffin embedded tissue blocks will be prepared from the tumor and adjacent normal colorectal mucosa in the Pathology lab. Sections will be stained by Hematoxalin and Eosin to diagnose the tumor phenotype. Additional sections will be mounted on coated slides and stained immunohistochemically by antibodies against human Cortactin . immunohistochemical expression of Cortactin will be evaluated in both the tumor sections and adjacent normal mucosa by using Immuno-reactive score. Expression of Cortactin in tumor tissues will be statistically correlated to degree of tumor differentiation, tumor invasion and nodal metastasis.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Jan 2021
- Primary completion30 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ColonStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Fifty, paired formalin-fixed and paraffin embedded tissue blocks from the colorectal carcinomas and adjacent non neoplastic colonic mucosa will be prepared and sectioned. From each block; one section will be stained by Haematoxaline and Eosine to establish diagnosis of colorectal carcinomas and to determine the degree of differentiation and degree of invasion of the underlying colonic tissues. Corresponding sections from each Formalin-fixed paraffin embedded tissue blocks will be immunohistochemically stained by anti- Human Cortactin antibody, to detect any association between cortactin expression and colorectal carcinoma.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maisa Hashem Mohammed, Sohag University
- Investigators
- Maisa H Mohammed, Principal investigator, a lecturer of pathology, Sohag faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225870
- Sponsor's protocol ID
- Soh-Med-22-01-33
- Status last verified
- Jul 2022
- First submitted
- 23 Jan 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Cortactin Expression is Associated With Increased Tumor Invasiveness and Nodal Metastasis in Egyptian Patients With Colorectal Adenocarcinomas
- ClinicalTrials.gov ID
- NCT05225870
- Acronym / sponsor ID
- Soh-Med-22-01-33
- Conditions
- Cancer Colon
- Keywords
- cancer colon, Cortactin, Immnuohistochemistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal carcinoma is one of the most aggressive malignant epithelial neoplasms affecting the gastrointestinal tract. The incidence of colorectal carcinoma is obviously increasing in developing countries, where the physical inactivity and the consumption of animal fat-rich food became more evident. Colorectal tumorigenesis is a multistep process which is initiated by adenoma and is terminated by carcinoma, the latter shows variable degrees of tumor differentiation and invasiveness. During the adenoma-carcinoma process; a series of genetic mutations occur. Detection of these genetic mutations will help in the development of novel therapeutic agents, which in turn will improve patients' outcomes. Cortactin (CTTN) is a Src kinase substrate, encoded by a gene located on chromosome 11. CTTN binds to and activates Arp 2/3 and stabilizes the dynamic actin assembly after its formation. So, it become clear that CTTN is involved in the formation of the leading-edges cellular protrusions.
Detailed description
Colorectal carcinoma is a highly lethal malignant epithelial tumor involving humans. The incidence of colorectal carcinoma is steadily increasing in developing countries, this could be assigned to low physical activity together with high consumption of animal fat-rich food. malignancy of the colon is a multistep process which is initiated by adenoma that proceeds to carcinoma, the latter includes a wide variety of tumor phenotypes. During the adenoma-carcinoma process; a series of genetic and epigenetic alterations occur. Detection of these genetic alterations is of great benefit in the future management of colorectal carcinomas. Cortactin (CTTN) is a Src kinase substrate, encoded by a gene located on chromosome 11. CTTN anchors the dynamic actin assembly . CTTN is implicated in the formation of the leading-edges cellular protrusions.the aim of this study is to evaluate expression of CTTN in 50 cases of colorectal adenocarcinomas and their adjacent normal colonic mucosae.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fifty, paired formalin-fixed and paraffin embedded tissue blocks from the colorectal carcinomas and adjacent non neoplastic colonic mucosa will be prepared and sectioned. From each block; one section will be stained by Haematoxaline and Eosine to establish diagnosis of colorectal carcinomas and to determine the degree of differentiation and degree of invasion of the underlying colonic tissues. Corresponding sections from each Formalin-fixed paraffin embedded tissue blocks will be immunohistochemically stained by anti- Human Cortactin antibody, to detect any association between cortactin expression and colorectal carcinoma.
| Arm | Type | Receives |
|---|---|---|
| patients with colorectal carcinoma | Other | Genetic: immunohistochemical stainingpatients with colorectal carcinoma will undergo colectomy. their colectomy specimens will be sectioned, tissue blocks will be prepared from tumor and adjacent normal mucosa. sections will be stained immunohistochemically by antibody against cortactin. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with colorectal carcinomas who underwent colectomy operations.
Key exclusion criteria (1 listed)
- specimens obtained by lower endoscopy only, patients who received pre-operative chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunohistochemical stainingsections from colorectal carcinoma will be immunohistochemically stained by anti-Cortactin antobody. | Genetic | patients with colorectal carcinoma |
Primary outcome
immunohistochemical evaluation of Cortactin expression
Time frame: 8 weeks
Fifty patients with colorectal adenocarcinoma will be enrolled in the study. Formalin-fixed and paraffin embedded tissue blocks will be prepared from the tumor and adjacent normal colorectal mucosa in the Pathology lab. Sections will be stained by Hematoxalin and Eosin to diagnose the tumor phenotype. Additional sections will be mounted on coated slides and stained immunohistochemically by antibodies against human Cortactin . immunohistochemical expression of Cortactin will be evaluated in both the tumor sections and adjacent normal mucosa by using Immuno-reactive score. Expression of Cortactin in tumor tissues will be statistically correlated to degree of tumor differentiation, tumor invasion and nodal metastasis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maisa H Mohammed principal investigator
a lecturer of pathology, Sohag faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immunohistochemical staining in people with Cancer Colon, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunohistochemical evaluation of Cortactin expression (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.